Rx Minute: Alzheimer’s Burden Will Balloon if New Treatments Are Not Found

Alzheimer’s Burden Will Balloon if New Treatments Are Not Found

A new report from the Alzheimer’s Association examines the future impact of Alzheimer’s disease (AD) and the potential impact of new treatments. The study finds that on our current trajectory Alzheimer’s disease in adults over 65 will cost $1 trillion per year by 2050 and a total of $20 trillion in the next 40 years. Medicare spending on AD will rise 600% while costs to Medicaid, other payers and patients will each rise 400%. The number of patients with AD will increase from 5.1 million today to 13.5 million in 2050.

New disease-modifying treatments could change that trajectory. A new treatment that delays the onset of disease by 5 years would push back the growth in new cases reducing the number of people with the disease by 43% and saving $447 billion a year by 2050. A treatment that slows the progression of AD by 5 years would reduce the number of people in the severe stage of the disease by over 80% and save $197 billion a year by 2050.

The study included medical costs to Medicare, Medicaid, private payers, and patients, but did not account for the additional burden on family caregivers and the cost of lost productivity, so the full societal benefits of effective treatments would be even higher.

Complexity and Execution Burden of Clinical Trials Are Rising

A recent report by Tufts Center for the Study of Drug Development (CSDD) finds that clinical trials are continuing to become more complex and time-consuming. Between 2000-03 and 2004-7, the median number of procedures per clinical trial increased by 49% while the total work burden per protocol grew by 54%.

As complexity increases so do eligibility criteria for volunteers, leading to lower volunteer recruitment and retention rates. The average number of eligibility criteria for volunteers increased by 58% and volunteer enrollment and retention rates declined by 21% and 30%, respectively.

Drug developers have increased the amount of information produced earlier in the process and, as a result, phase 1 and 2 protocols showed the largest annual growth in complexity and execution burden, respectively. Phase 4 also saw significant annual growth reflecting increased post-approval requirements. Phase 3 trials, on the other hand, saw much less growth in complexity, which, according to Tufts, may be due to efforts to control costs of these expensive, late-stage studies.

At each stage of development different therapeutic areas vary in the complexity and difficulty of trials. For example, in phase 1, protocols targeting cardiovascular disease, immunologics, and anti-infectives had the highest execution burdens of all therapeutic areas. In phase 3 the most complex protocols, as measured by total procedures, were in immunology, CNS, oncology, anti-infectives, and endocrine disorders.